October 16, 2019

The U.S. FDA has approved an expanded indication for Xofluza™ (baloxavir marboxil) oral tablets, manufactured by Genentech. The product was initially approved in 2018 to treat acute, uncomplicated influenza in patients who are at least 12 years of age, have been symptomatic for no more than 48 hours, and who are otherwise healthy. It can now also be used to treat patients who are at high risk of developing influenza-related complications.

Influenza—more commonly known as the flu—is a highly contagious viral respiratory illness. Anywhere from 3% to 11% of the US population has symptomatic flu illness each flu season, according to the US Centers for Disease Control and Prevention (CDC). In some cases, the flu can be so severe as to require hospitalization, and may even be fatal. Potential complications of the disease include bacterial pneumonia and worsening of chronic medical conditions such as congestive heart failure, asthma, or diabetes.

In a clinical study, Xofluza significantly reduced the time to improvement of flu symptoms compared to placebo in patients who were at least 12 years of age and met CDC criteria for being at high risk of influenza-related complications. The CDC’s criteria include individuals who have conditions such as asthma, chronic lung disease, diabetes, heart disease, and morbid obesity, or who are 65 years of age or older.

Xofluza requires a one-time administration within 48 hours of developing flu symptoms. Recommended dosing is two 20mg tablets taken once in patients who weigh at least 40kg (88 pounds) and less than 80kg (176 pounds). Patients who weigh 80kg or more should take two 40mg tablets once. Xofluza can be taken with or without food, but should not be taken with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids, or oral supplements (such as calcium, iron, magnesium, selenium, or zinc).

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